Consulting Wallah › Device Explorer › Other devices › Orthodontic clasp, metal, custom-made
Device Explorer · FDA GUDID · GMDN 40734

Orthodontic clasp, metal, custom-made

A dental device made of cast metal material intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet the specifications of an individual patient. This is a single-patient device that is used for the dur

US‑registered devices116in commercial distribution
Companies2labelers on GUDID
Single‑use97%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Allesee Aoa-Pro11599%
Dental Morelli Ltda11%

Top labelers

CompanyDevicesShare
Allesee Aoa-Pro11599%
Dental Morelli Ltda11%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

4mm Hex Screw, Pk/10TS/Hex AccessoriesTS/Applecore AccessoriesTS AccessoriesAppleCore ScrewMiniScope Mechanism 27mm, setMiniScope Mechanism 24mm, setMiniScope Mechanism 21mm, setMiniScope Mechanism 18mm, setAppleCore Screw, Pk/104mm Round Spacer, Pk/103mm Round Spacer, Pk/102mm Round Spacer, Pk/101mm Round Spacer, Pk/105.5mm Hex Screw, Pk/10Herbst Sleeves, set

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EJFBRACKET, METAL, ORTHODONTIC113
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC1
KMYPOSITIONER, TOOTH, PREFORMED1
EHOBAR, PREFORMED1

GMDN & GCC registration

  • GMDN code 40734 · non‑implantable
  • Single‑use 97% · sterile 0% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many orthodontic clasp, metal, custom-made products are registered in the US?

116 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic clasp, metal, custom-made", from 2 companies. The largest labeler is Allesee Aoa-Pro with 99% of records.

Which FDA product codes apply?

EJF (BRACKET, METAL, ORTHODONTIC), DYJ (RETAINER, SCREW EXPANSION, ORTHODONTIC), KMY (POSITIONER, TOOTH, PREFORMED), EHO (BAR, PREFORMED)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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